NCT04432571Completed
ADAPT for Adolescents Adolescents
An Adaptive Strategy for Preventing and Treating Lapses of Retention in HIV Care for Adolescents
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
Adolescents and young adults (AYA) with HIV face unique challenges to engagement in care and their ability to achieve optimal health outcomes. The investigators hypothesize that developmentally-tailored behavioral interventions will improve engagement in HIV care and viral suppression (per current MOH guidelines) among AYA with HIV in Kenya. This two stage study will initially randomize 880 AYA with HIV to either standard of care (SOC) or electronic navigation to prevent treatment lapse. Participants who have a lapse will be re-randomized to SOC, in-person peer navigation, or conditional cash transfers. Formative work will be conducted initially to tailor the interventions to AYA and then later to assess AYA perception, experience, and satisfaction with the interventions. We will evaluate the most effective and cost-effective intervention and sequence of interventions to inform HIV program managers, public policy makers, and other key stakeholders the best approaches to improve engagement of care of AYA with HIV.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 880 (actual)
- First submitted
- 4 Jun 2020
- Start date
- 6 Apr 2021
- Primary completion date
- 13 Sept 2025
- Lead sponsor
- Washington University School of Medicine
- Diseases
- HIV
- NCT number
- NCT04432571
What you commit to
- Study type: Interventional
- Participants enrolled: 880
- From 6 Apr 2021 to the primary completion date, 13 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- AYA who participated in ADAPT-R,
- Those planning to move out of Kisumu County, those acutely ill and requiring hospitalization,
- Those who report sharing phones but have not disclosed to the person sharing the phone
Who the study is looking for
- HIV-infection, on or initiating ART,
- 14-24 years of age,
- Living \> 6 months in Kisumu County, Kenya in previous year,
- Capable of informed consent (\> 18 years) or with a legal caregiver available for consent (14-\<18 years),
- Access to a cell phone,
- Ability to read or be read short message service (SMS) messages,
- Willingness to be contacted by clinic upon missed appointment,
- For AYA who report phone sharing must have disclosed to the person sharing the phone.
- Additionally, we will include AYA who are aware of their HIV status or whose caregivers agree to assisted disclosure.
Age in the registry: 14 years to 24 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kenya Medical Research Institute Coordinator of this site? Confirm its status | Kisumu | Kenya | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.